Rheumatoid Arthritis
Conditions
Brief summary
This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate（MTX）in patients with active rheumatoid arthritis (RA). The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.
Detailed description
This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with MTX in patients with active RA. The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.
Interventions
DRUGplacebo
Intravenous repeating dose
DRUGmethotrexate
Oral repeating dose
DRUGocrelizumabu 50mg
Intravenous repeating dose (50mg)
DRUGocrelizumabu 200mg
Intravenous repeating dose (200mg)
DRUGocrelizumab 500mg
Intravenous repeating dose (500mg)
Sponsors
Chugai Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of RA for ≧6 months according to the revised 1987 ACR criteria for the classification of RA. * Adult patients, ≧20 years of age. * Receiving methotrexate at a dose of 6 to 8mg/week（oral）for ≧12 weeks, with a stable dose for the last 4 weeks before treatment. * Positive serum RF.
Exclusion criteria
* Rheumatic autoimmune disease other than RA, or Significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome).Patients with secondary Sjögren's syndrome or secondary limited cutaneous vasculitis with RA are eligible. * Functional Class Ⅳ as defined by the ACR Classification of Functional Status in RA. * History of or current inflammatory joint disease other than RA (e.g., gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (e.g., systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or other overlap syndrome). * Any surgical procedure (except for minor surgeries requiring local or no anaesthesia and without any complications or sequelae) within 12 weeks prior to or planned within 24 weeks after baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with ACR20 response. | week 24 |
Secondary
| Measure | Time frame |
|---|---|
| EULAR response rate. | Every 4 Weeks, from Week 4 to Week 24 |
| DAS 28, HAQ-DI score. | Every 4 Weeks, from Week 4 to Week 24 |
| FACIT Fatigue Scale score | Weeks 4,12,and 24 |
| Percentage of patients with ACR20, 50, and 70 response, and the components of this outcome. | very 4 Weeks, from Week 4 to Week 24 |
| Incidence of human anti-human(ocrelizumab) antibodies (HAHA) | Length of study |
| Pharmacokinetics and Pharmacodynamics of ocrelizumab. | Length of study |
| Weeks 4,12,and 24 | Length of study |
Countries
Japan
Outcome results
None listed